510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020538Substantially Equivalent

Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series

Boehringer Laboratories, LLC, Norristown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020538 is the FDA 510(k) clearance record for BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES, a class II device, cleared for Boehringer Laboratories on under FDA product code DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)). FDA records list 44 510(k) clearances for Boehringer Laboratories, from to . As of , FDA records show no recalls naming K020538.

Clearance record

Decision date
Received
(85 days to decision)
Product code
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Regulation
21 CFR 880.5780
Device class
Class II
Review panel
General Hospital
Applicant
Boehringer Laboratories 500 E. Washington St., Norristown PA
510(k) summary
Statement
Third party review
No

Clearances, product code DWL

Trailing 12 months

FDA records hold no clearances under product code DWL in the trailing twelve months.

FDA records show no clearances under product code DWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260